The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor, serotonin 2A (5-HT2A) receptor, and serotonin transporter (SERT) in healthy subjects.
Healthy male and female subjects between 18 and 55 years old (inclusive);
BMI inclusive of 18-32 kg/m2 at screening and a minimum weight of 50 kg;
Willingness to remain in the hospital research unit for the duration of the inpatient period.
Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, gastrointestinal, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;
Clinically significant abnormal findings in vital sign assessments, supine SBP > 140 mmHg or < 90 mmHg, or supine DBP >90 mmHg or < 50 mmHg or supine pulse rate > 100 bpm or < 45 bpm at Screening;
History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study;
Any condition which would preclude MRI or PET/CT examination (eg, implanted metal, claustrophobia, unable to fit in PET/CT or MRI scanners);
Parallel
ITI-1284 10 mg
DrugITI-1284 tablet
ITI-1284 20 mg
DrugITI-1284 tablet
6
Treatment groupsSee each treatment group below.
% Receptor occupancy
Percent change of binding potential from baseline
Pharmacokinetics: AUC0-t
Area under the plasma drug concentration-time curve (AUC) from time zero to the last measurable concentration
Pharmacokinetics: Cmax
Maximum plasma concentration
Pharmacokinetics: Tmax
Time of maximum plasma concentration
Percentage of subjects with treatment-emergent adverse events
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